Title:Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries
VOLUME: 7 ISSUE: 2
Author(s): Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar and Akshay Monga
Affiliation:Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Rhydburg Pharmaceuticals Ltd., New Delhi-110009
Keywords:Generic drug, latin American regions, regulatory requirements, product registration, LATAM
region, administrative documents.
Abstract:The product registration in the rest of the World is a challenging task because the regions
under it are not harmonized. CIS and Latin American regions come under semi-regulated
market. These regions have somewhat harmonized their regulatory organization. The significance
of an emerging market is increasing globally. It is important for pharmaceutical companies to be
up-to-date with the latest regulatory development. Both the regions follow their regional checklist
for Drug Product Registration. Latin America includes a group of countries like Brazil, Guatemala
and Peru etc, whereas CIS includes Russia, Ukraine, Uzbekistan, Armenia and Tajikistan etc.
